Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients

NCT01325766 | Unknown

• 1 other identifier: 13424
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US. Incorporation of regular exercise into the lives of patients with CF is of interest because it may improve lung function and quality of life. Yoga is an activity that may benefit patients with CF in many ways including strengthening muscles of breathing, improving lung function, and reducing stress which could improve quality of life and adherence to therapies. Yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but has not yet been studied in CF. The investigators hypothesize that yoga will be an activity that is safe and tolerable for CF patients 12 to 25 years of age. The primary aim is to investigate the safety and tolerability of an 8 week yoga program for patients with CF. The secondary aim is to determine the effect of yoga on many aspects of CF disease including respiratory symptoms, adherence to regular CF therapies, quality of life, lung function, exercise tolerance, and nutritional status. The long-term goal is to use the data obtained in this study to design a future study of the efficacy of yoga in a larger population of CF patients at multiple CF centers. This research has the potential to influence the prevention and treatment of CF by providing data which could be used to help understand the most appropriate and beneficial type of physical activity for CF patients.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Yoga

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety

  Determine if a yoga program is safe for CF patients by monitoring for adverse events throughout the study.

  16 weeks

• Pain Scores on the Visual Analog Scale as a measure of tolerability

  Participants will be given a tolerance questionnaire after each yoga session which will assess their degree of musculoskeletal and chest pain on a visual analog scale. Vital signs will also be measured before and after each yoga session.

  16 weeks

Secondary Outcomes (6)

• Quality of Life

  16 weeks

• Respiratory symptoms

  16 weeks

• Treatment adherence

  16 weeks

• Pulmonary function

  16 weeks

• Ease of breathing

  16 weeks

Study Arms (2)

Yoga (immediate start) group

ACTIVE COMPARATOR

This arm will start yoga sessions immediately after screening and will continue sessions for 8 weeks. This group will then continue with home yoga for an additional 8 weeks.

Other: Yoga

Yoga (waitlist) group

ACTIVE COMPARATOR

This arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9.

Other: Yoga

Interventions

Yoga OTHER

Yoga 2 sessions per week for 8 weeks

Yoga (immediate start) group; Yoga (waitlist) group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• o Diagnosis of CF by: Sweat chloride ≥60meq/L on two occasions or CFTR genotype with two CF disease-causing mutations and one or more phenotypic features of CF
• Age ≥12 and ≤25 years
• FEV1 ≥40 % predicted at screening visit
• Informed consent and assent

You may not qualify if:

• Wheezing on auscultation of the chest at the enrollment visit
• Oxygen saturation \< 90 % at the enrollment visit
• Initiation of treatment with oral, inhaled or intravenous antibiotics for an acute respiratory infection in the 2 weeks preceding the enrollment visit
• Pregnancy
• History of lung transplant
• Practiced yoga regularly (≥1 time per week) in the month prior to enrollment
• Current enrollment in a therapeutic clinical trial
• Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Firland Foundation: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Yoga

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Jennifer Ruddy, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon McNamara

CONTACT

206-987-3921; sharon.mcnamara@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 30, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

US (1)